The subject matter disclosed herein relates to a method for collecting and assigning patient data for evaluation in a clinical trial.
One method for assessing the safety of a new medication involves the performance of a clinical trial. Clinical trials generally comprise a variety of different guidelines or requirements adapted to evaluate the safety of the medication in a reliable and consistent manner. As an example, the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) has developed a series of guidelines for certain categories of clinical trials.
ICH document E14 provides recommendations concerning the design, conduct, analysis, and interpretation of clinical studies to assess the potential of a drug to delay cardiac repolarization. The E 14 recommendations include a manner for assigning patient electrocardiogram (ECG) data to a group of readers such that the reliability and consistency of the reader's assessment is optimized. The ECG data, which may comprise tens of thousands of individual ECG recordings, is generally manually assigned to each reader. The problem is that the process of manually assigning the ECG data is time consuming and labor intensive.